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Greater Occipital Nerve (GON) Block Effectivity in the Treatment of Chronic Migraine: 6 Months Follow up

B

Bozok University

Status and phase

Withdrawn
Phase 4

Conditions

Migraine Disorders

Treatments

Drug: saline
Drug: bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT02578719
B.10.4.ISM.4.06.68.49/

Details and patient eligibility

About

This study evaluates effectiveness of greater occipital nerve blocks with bupivacaine compared to placebo in chronic migraine patients.

Full description

The greater occipital nerve (GON), which derives most of its fibers from the C2 dorsal root, is the primary sensory nerve of the occipital region. The response to GON blockade was not simply dependent on the direct local anesthetic effect of the injection . The mechanism of action might have been via changes in brain nociceptive pathways. Another possible explanation for these findings is, therefore, that GON injections initiated diffuse noxious inhibitory controls, independent of anesthetic effect . Neurophysiological and clinical data suggest there is a functional connection between the sensory occipital segments and the trigeminal nociceptive system in humans.

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Chronic migraine headache according to International Headache Society Classification Criteria
  • Patients who are not using any prophylacting agent

Exclusion criteria

  • patients given similar treatments before
  • pregnant women
  • hereditary diseases causing bleeding
  • patients who have intracranial tumor or operation in posterior fossa
  • allergic reactions to local anesthetics.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 2 patient groups, including a placebo group

drug: bupivacaine
Placebo Comparator group
Description:
Placebo comparator: bupivacaine first 3 months 0.5% 1 cc bupivacaine diluated with 1.5 cc saline enjection will be used in GON block once a month. If effectiveness is proved then blindness will be opened and all patients will be blocked by 0.5% 1 cc bupivacaine diluated with 1.5 cc saline once a month for 3 months.
Treatment:
Drug: bupivacaine
placebo
Placebo Comparator group
Description:
first 3 months 2.5 cc saline enjection will be used in GON block once a month. If effectiveness is proved then blindness will be opened and all patients will be blocked by 0.5% 1 cc bupivacaine diluated with 1.5 cc saline once a month for 3 months.
Treatment:
Drug: saline

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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